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CTRI Number  CTRI/2023/06/053947 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Correlative 
Study Design  Other 
Public Title of Study   To check the smartphone use & its behavioral changes among nursing students 
Scientific Title of Study   A correlative study on smartphone usage & behavioral changes among nursing students of selected college of Udupi district, Karnataka.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms. Susanna Prarthana 
Designation  2nd year PBBSc Nursing student 
Affiliation  Manipal College of Nursing 
Address  1st floor Manipal College of Nursing MAHE Manipal
1st floor Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  8762195329  
Fax    
Email  susansusam8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Binil V  
Designation  MSc Nursing PhD Associate Professor 
Affiliation  Manipal College of Nursing 
Address  Department of Mental Health Nursing 6th floor Manipal College of Nursing MAHE Manipal
Department Of Mental Health Nursing 6th floor Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9844387432  
Fax    
Email  vp.binil@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Binil V  
Designation  MSc Nursing PhD Associate Professor 
Affiliation  Manipal College of Nursing 
Address  Department of Mental Health Nursing6th floor Manipal College of Nursing MAHE Manipal
Department of Mental Health Nursing 6th floor Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9844387432  
Fax    
Email  vp.binil@manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Susanna Prarthana 
Address  Manipal College of Nursing, MAHE, Manipal 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Susanna Prarthana  College of Nursing   1st Floor 105 Room Number Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA 
8762195329
91-08202522443
susansusam8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nursing Students  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  as it is a descriptive study there is no intervention and comparator agent  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Nursing students who are willing and present during the time of study.  
 
ExclusionCriteria 
Details  Nursing students who are not willing and not present during the time of study.
those students who are sick.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the smartphone usage & its behavioral changes among the nursing students.   baseline  
 
Secondary Outcome  
Outcome  TimePoints 
To find the relationship between smartphone usage & behavioral changes among nursing students  baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nill 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A correlative study on smartphone usage and its behavioral changes among the nursing students of selected college of Udupi District. Purpose of the study is to determine the smartphone usage and its effect on behavior among nursing students. This information can be used by health professionals and academicians to increase the educational quality to get better performance from the students. The objectives of the study are to assess the smartphone usage and the behavioral pattern while using the smartphone among the nursing students. to find the relationship between smartphone usage and behavioral changes among the nursing students.    
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